MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG CARB-BITE MAYO-HEGAR NEEDLE HOLDER

Model Number 121135

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that the instrument was being used on the field in the patient's right leg during insertion of an intramedullary nail (femur).A piece of the tip was found in the leg while using c-arm during procedure.The piece was removed from the patient and placed in a specimen cup with lid.The instrument and specimen cup were immediately removed from the sterile field and given to circulator.An x-ray was taken to confirm that no retained objects remained.There was no consequence to patient as a result of the product problem and no procedural delay occurred.

Manufacturer Narrative

The instrument was not returned and it was not possible to determine the manufacturing lot number.However, on the basis of the available information it was established that the device was manufactured in the second quarter of 2015.The device history records of all batches of the device that were manufactured during this period were reviewed.No problems were found.The device's complaint history was reviewed for the period from 2015 through 2022 and no problems were found.The investigation has been closed.Should additional information become known, the complaint will be reopened.

• Brand Name: CARB-BITE MAYO-HEGAR NEEDLE HOLDER
• Type of Device: NEEDLE HOLDER
• Manufacturer (Section D): GEOMED MEDIZIN-TECHNIK GMBH & CO. KG; ludwigstaler strasse 27; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): GEOMED MEDIZIN-TECHNIK GMBH & CO. KG; ludwigstaler strasse 27; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: hanno haug ; ludwigstaler strasse 27; tuttlingen, bw 78532 ; GM 78532
• MDR Report Key: 16110153
• MDR Text Key: 307889185
• Report Number: 8010168-2023-00002
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 10381780377160
• UDI-Public: 10381780377160
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 121135
• Device Catalogue Number: 121-135 / AR 200-16-61
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 01/05/2023
• Supplement Dates Manufacturer Received: 01/10/2023
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Sex: Male